Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: POLYVIOLENE SUTURE
• Generic Name: Suture, nonabsorbable, synthetic, polyester
• Regulation Number: 878.5000
• Applicant: Look, Inc.; 2020 Lonnie Abbott Industrial; Blvd. P.O.Box 2087; Ada, OK 74820
• PMA Number: N80950
• Supplement Number: S003
• Date Received: 03/21/1986
• Decision Date: 06/09/1986
• Product Code: GAS
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No